Articles Tagged withMetallosis

I have written about artificial hip litigation on this site more than any other area of product liability law, and for a very good reason: there is a lot to write about. Metal-on-metal hips have gravely injured tens of thousands of people, and new victims are undergoing revision surgeries each week to remove defective hips. One current active litigation involves Smith & Nephew “Birmingham” artificial hips. MDL 2775 is the multidistrict litigation court handling hundreds of lawsuits filed against medical device maker Smith & Nephew for these (allegedly) defective artificial hips. There are several artificial hip products involved in MDL 2775:

Birmingham Hip Resurfacing System (BHR). The multidistrict litigation court was first organized to handle these BHR lawsuits. The BHR system is a type of metal-on-metal artificial hip, but in resurfacing procedures the hip “ball” bone is shaped and resurfaced with a smooth metal covering and a metal shell is implanted into the hip socket, thus creating a metal-on-metal connection or “articulation.” As with most metal-on-metal artificial hips, Smith & Nephew uses cobalt and chromium to construct both of these resurfacing components. These metals have been shown to wear away and leach into the blood and tissue of the patient, causing all kinds of symptoms and problems, including metallosis.

BHR Hip Components Used in Total Hip Arthroplasty (THA). These hip implants are constructed with Smith & Nephew BHR components and non-BHR components, but instead of resurfacing the “ball-bone” with a metal covering the bone is removed and a metal ball component is implanted. MDL 2775 added these Total Hip Arthroplasty (THA) cases to the litigation shortly after the MDL launched.

Do you have pain that seems irregular after Hip Surgery? Today’s guest will guide us through the expectations of hip surgery, what it is like to go through the surgery, what rehab is like, and what happens to a person when an artificial hip fails inside the body.

Amy Dougherty a physical therapist on the Outer Banks of North Carolina, is the owner of Outer Banks Physical Therapy. She graduated from the University of North Carolina at Chapel Hill, where Clay also attended college and Law School. Loved by her patients, she is an outstanding Physical Therapist and will explain how hip surgery impacts your body and what happens to the body when hip surgery fails.

If you have any interest in artificial hips, you need to follow the work of Dr. Steven Tower. An orthopedic surgeon in Anchorage Alaska, Dr. Tower has built a one-man research laboratory studying the horrifying health effects of chrome and cobalt hip components. While hip manufacturers have been slow to produce meaningful studies on the ill-effects of metallosis on the human body, Dr. Tower decided to study his own patients. What he discovered could save lives.

Dr. Tower’s Backstory

Steven Tower’s story is remarkable. He is featured in the Netflix medical device documentary The Bleeding Edge. Dr. Tower is an avid cyclist and needed a hip replacement several years ago. He chose the DePuy ASR metal-on-metal artificial hip because it was marketed to “exceptionally active individuals.” Several months after his hip replacement surgery, however, Dr. Tower noticed a tremor in his hand. His ears started ringing, his thinking became confused and he began repeating himself when he spoke. One night while attending a medical conference Dr. Tower had a mental breakdown and trashed his hotel room. He wrote all over the walls with sharpies and pens, and wrote on the hotel mirrors with soap. When he returned home he measured the metal levels in his blood, and the test results revealed 100 times the normal amount of cobalt that should be in his body. Dr. Tower soon arranged to have his metal hip components removed in a revision surgery. Within a month his thinking cleared and his other symptoms mostly disappeared. He was relieved, but also intrigued.

For many years my clients with failing artificial hips have asked me about the health effects of high cobalt and chromium levels in the body. These questions usually arise after clients get blood work done and the test reveals abnormally high metal levels. If you are reading this article, you probably already know that cobalt and chromium are two metals used in the construction of most metal-on-metal (MoM) artificial hip systems. In fact, cobalt and chromium are used to make artificial hips that are not metal-on-metal but instead use polyethylene liners, or ceramic heads, or other non-metal components. When metal components grind together, as they naturally do when a MoM artificial hip is implanted in a person, very small metal particles can be released into the tissue and the bloodstream. I wrote about the health effects of metallosis on the body over a year ago. You can check out that article here.

Dr. Steven Tower, an orthopedic surgeon in Alaska, recently gave a fascinating (and alarming) talk about the many neurologicalproblemshe has observed in hip patients with elevated cobalt levels in the body. For years the focus following hip replacement surgeries has been on the physical condition of the hip itself. Dr. Tower has concluded that this approach is wrong, or at least incomplete, and he has seen that often the first signs of trouble with hip replacement patients are neurological symptoms. He has even given it a name: Arthroplasty Cobalt Encephalopathy, or ACE.

Behind every metal-on-metal (MoM) artificial hip that fails, there is a person and a story. Artificial hip manufacturers may see only a faceless crowd of victims. These defendant companies may attempt to resolve the claims in bulk and move on to market the next blockbuster medical device. But in that crowd of plaintiffs are thousands of individuals uniquely injured by a product that was implanted in their bodies. The product failure often requires revision surgery, and the injuries that result from the artificial hip failures change lives forever: accomplished tennis players no longer play tennis; couples no longer travel or walk together on a beach; others have to resign from jobs they love because they cannot sit a desk for any length of time. Each of these people has a unique story to tell.

In the next three posts, I will share one woman’s story. “Suzanne” [not her real name] received a metal-on-metal (MoM) artificial hip in 2006 after years of pain from arthritis. The hip was recalled in 2010, and Suzanne was forced to undergo revision surgery in 2011. This is her story:

“What did they know and when did they know it?” When something goes wrong with a medical device, this eventually becomes the key question. Unfortunately for Depuy Orthopaedics (Depuy), a lot has gone wrong with its metal-on-metal (MoM) hip implants over the past ten years. And to make matters worse, recently released documents* show Depuy knew it would have problems with its MoM hip implants decades ago.

Depuy MoM Hip Implants: An Overview

Hip implants have been around for a long time. They can be made of various materials. Some older models use a polyethylene cup and a metal ball to create the artificial hip joint. While this combination works well, it’s not perfect. Engineers have looked for other materials to find a hip joint that can last longer with fewer adverse effects.

One attempted solution was to have both the cup and ball made out of metal, hence a metal-on-metal hip joint. However, the performance of these hip implants was even worse than joints that used polyethylene and metal. Problems with MoM hip implants included significant pain, bone loss, hip implant failure and metallosis.

As a result of these problems, thousands of lawsuits have sprung up, not just against Depuy, with its ASR and Pinnacle MoM implants, but other MoM hip implant manufacturers such as Biomet and Stryker. Many of the Depuy lawsuits have been consolidated into multi-district litigation, or MDL. A few initial bellwether trials involving the Depuy Pinnacle have resulted in massive verdicts against Depuy, which I wrote about here.

Basically, things have not been looking good for Depuy. And they just got worse.

Not all artificial hips fail. Many total hip replacement surgeries are successful. Unfortunately, the metal-on-metal artificial hips have “failed” at a rate much higher than previous artificial hips, whose components typically consisted of a combination of metals, plastics, and ceramics. The metal-on-metal design placed a metal ball or head directly into a metal acetabular cup. By using a metal cup and a metal ball, these artificial hips forced metal to rub against metal with the full weight and pressure of the human body.

In any hip replacement surgery, there is a period of rehabilitation. Even with great surgery results, the patient will suffer some soreness, stiffness, and a period to regain strength, mobility, and comfort. From the dozens of people I have spoken with over the years who have undergone hip replacement surgery, even successful hip replacements do not turn you into a completely pain-free eighteen year old athlete.

For many patients, however, particularly those who received the metal-on-metal hip, there may come a point when they wonder if their artificial hip has failed. But given that all hip surgeries initially come with some discomfort and pain, how do they know if their hip has failed.

The latest Depuy Pinnacle Hip bellwether trial is underway in Dallas, Texas. All bellwether trials are important, but this one is more important than most. After all, this trial follows an astonishing result in the second bellwether trial, where a jury awarded five plaintiffs more than $500,000,000.00 in damages for injuries caused by the Depuy Pinnacle hip. More about that case in a moment. But this third bellwether trial is critically important to Depuy and Johnson & Johnson (the Depuy Pinnacle manufacturers) who desperately need a court victory after the second bellwether trial. Another large verdict for the plaintiffs will most likely change the fate of any global settlement with the eight thousand plaintiffs who still have cases against Depuy and Johnson & Johnson.

Third Depuy Pinnacle Bellwether Trial

Judge Kinkeade, the federal judge in Texas overseeing the Depuy Pinnacle multidistrict litigation, selected seven individual cases to be consolidated in the current bellwether trial. The plaintiffs are Marvin Andrews, Kathleen Davis, Sandra Llamas, Rosa Metzler, Judith Rodriguez, Lisa Standerfer, and Michael Weiser. All the plaintiffs are from California. Their cases were transferred to the Depuy Pinnacle MDL in Dallas, Texas.

Over the years I have worked with many people who had hip replacement surgery. Many of these clients discovered high metal levels in their bodies from metal-on-metal (MoM) hip components. Often the person would let me know that she had her metal levels checked and that the blood work came back with abnormally high readings of cobalt, chromium, or other metals. Still, the treating physician would occasionally dismiss the blood work results. At least one doctor told a patient, “no one knows the effects of higher metal levels on the body. We haven’t studied the impact of metallosis sufficiently. It is nothing to be worried about at this point.”

Sadly, this isn’t true. And it’s not the best medical advice. There have been several studies over the years that looked at metallosis in the body derived from metal-on-metal hip components. The first incident of metallosis from MoM hip implants was reported in 1971. Since then, doctors have been reporting the higher incidence of metallosis in patients who received MoM artificial hip implants. Several scholarly studies have been conducted, including a recent one whose results were published this month examining the impact of metallosis on the cells of patients.